NCT03975881

Brief Summary

Context: Suicide is the 2nd cause of death during adolescence Compliance with post SA care is low and variable with effective compliance ranging from 17.5% to 47% . Therefore, prevention programs should also focus on high-risk individuals with a previous history of SA. Adolescents and young adults are considered to be digital natives, they are therefore a relevant population for the testing of Smartphone Application. Project: The Investigators propose an innovative and new approach to prevent SA and Suicide for patients, based on a mobile healthcare application. The program is an add-on to the usual care process. Study: In a multicentric randomized pilot study with 15 to 35 years-old patients having previous SA, the primary goal for pilot study is to observe the filling rate of the application (feasibility).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 5, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

April 9, 2018

Last Update Submit

June 4, 2019

Conditions

Suicide Attempt by Scalding

Keywords

Suicide attemptsdigital deviceadolescentadults

Outcome Measures

Primary Outcomes (1)

  • Evaluate the usage rate of the Medical Companion application over a period of 6 months.

    Ratio calculation (r) : r = (number of uses done) / (number of uses expected)

    6 months

Secondary Outcomes (8)

  • Evaluation of the use rate of the application over 6 months

    6 months

  • Evaluation of the use rate of the application over 6 months

    6 months

  • Evaluation of suicidal ideation after 6 months of use of the application,

    6 months

  • Evaluation of suicidal recidivism at 6 months

    6 months

  • Assessment of the compliance rate at recommended care

    6 months

  • +3 more secondary outcomes

Study Arms (1)

Open Label

EXPERIMENTAL

Patients aged 15 to 35 who made a suicide attempt and went through the emergency departments of the participating hospitals (Nantes, Angers, Rennes and Poitiers).

Other: application on smartphone

Interventions

application on smartphoneOTHER

The aim of this study is to test the feasibility of our approach of preventing suicide relapse with the use of a smartphone application.

Also known as: MEDICAL COMPANION
Open Label

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Boy or girl, aged 15 to 35 years and having made a suicide attempt within 96 hours requiring emergency admission.
  • Informed and signed consent of patient and parents (if applicable)
  • Patient affiliated to social security

You may not qualify if:

  • Patient with a severe psychiatric condition such as, schizophrenia, autistic spectrum disorder and antecedent of more than one suicide attempt (not counting this).
  • Patient without smartphone under iOS (mobile operating system developed by Apple) or Android, or without easy access (eg boarding school, social center ...)
  • Patient with an intellectual disability making it impossible to use the application (clinically estimated).
  • Absence of motivation in relation to the study.
  • Patient who does not want or can not give informed consent or understand it.
  • Patient whose follow-up seems difficult for psychological, geographical or social reasons, according to the judgment of the investigator
  • Not affiliated to social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU d'Angers

Angers, France

Location

CH Poitiers

Poitiers, France

Location

CH Rennes

Rennes, France

Location

Related Publications (1)

  • Mouchabac S, Leray P, Adrien V, Gollier-Briant F, Bonnot O. Prevention of Suicidal Relapses in Adolescents With a Smartphone Application: Bayesian Network Analysis of a Preclinical Trial Using In Silico Patient Simulations. J Med Internet Res. 2021 Sep 30;23(9):e24560. doi: 10.2196/24560.

    PMID: 34591030DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Fanny GOLLIER BRIANT

    Nantes University Hospital

    STUDY CHAIR

Central Study Contacts

Fanny GOLLIER BRIANT

CONTACT

0253482653fanny.gollierbriant@chu-nantes.fr

Olivier BONNOT

CONTACT

0253482653olivier.bonnot@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Patients aged 15 to 35 who made a suicide attempt and went through the emergency departments of the participating hospitals (Nantes, Angers, Rennes and Poitiers).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

June 5, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 5, 2019

Record last verified: 2019-05

Locations

FR(3)